Data mining of adverse drug event signals for pembrolizumab based on FAERS
CUI Yu
WANG Suzhen
GAO Yuxuan
YU Lili
Abstract：Objective To mine and analyze the adverse drug event signals of pembrolizumab,so as to provide reference for safe medication in clinic.Methods Adverse event reports from Q4 2014 to Q4 2022 were extracted from the Food and Drug Administration Adverse Event Reporting System database,and data mining was conducted using reporting odds ratio method and Medicines and Healthcare Products Regulatory Agency method.Results A total of 853 adverse event signals were obtained in the reports of pembrolizumab as the primary suspect drug after screening,and the signals with the highest intensity were immune-mediated hypothyroidism,immune-mediated kidney disease,and immune-mediated gastritis.The top 50 adverse events for signal strength involved a total of 17 systems,including diseases of the hepatobiliary system,endocrine system,and immune system.Conclusion The study finds a variety of adverse event signals not reported by the drug label,such as immune-mediated cystitis,adrenocorticotropic hormone deficiency,and tumour hyperprogression,which can provide references for clinical safe drug use.
Keywords：disproportional analysispembrolizumabadverse drug eventssignal mining
Publication Date：2025-11-30
Online Publishing Date：2026-08-26(First online date of this platform, not the publication date of the document)
Pages：6( 1450-1455 )